A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: AIMD Companies

St. Jude Starts Trial of Accent MRI Pacemaker and Tendril MRI Lead

Posted on by Posted in Bradycardia, Cardiac Pacing, MRI-safe, St. Jude Medical
St Jude's ACCENT MRI MRI-compatible pacemaker. Report by David Prutchi PhD

Image Credit: St. Jude Medical

Today St. Jude announced the first implant in its Accent MRI(R) Pacemaker and Tendril MRI(R) Lead IDE Study (MRI Study). The ultimate goal of the study is to determine if patients with these devices can safely undergo full-body, high resolution Magnetic Resonance Imaging (MRI) scans to better accommodate their medical needs. The investigational Accent MRI Pacemaker system from St. Jude Medical offers an advanced pacing platform that provides wireless telemetry and algorithms to help address individual patient conditions.

Continue reading→

Digikon’s History

Posted on by Posted in Bradycardia, Cardiac Pacing, Digikon, History, Museum

Digikon model LD451 Ventricular Inhibited Pulse GeneratorIn response to my post “A Challenge to History Buffs:  Who Was Digikon?“, Paolo Pagani sent me the following message:

“Digikon was in the years 1977-1985 the brand name product in Italy by Biotec Biomedical Technologies of Bologna – ITALY.

Pacemakers were a Digikon O.E.M. production for the trading company of Milan Italy KONTRON already a distributor in Italy of Medtronic.

Biotec developed the first pacemaker VVIR based on physiological changes in thoracic impedance due to respiration. (Biotec RDP-3)

Biotec-Bologna was acquired by Medtronic in August 1985.”

Thank you Paolo!

 

St. Jude Seeks Retraction of Heart Rhythm Journal Manuscript by Dr. Robert Hauser Regarding the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads

Posted on by Posted in Cardioversion/Defibrillation, St. Jude Medical

St Jude Medical Riata LeadsSt. Jude announced it is seeking a retraction of the manuscript accepted for publication in the Heart Rhythm Journal by Dr. Robert Hauser, et al., titled, “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads.” St. Jude claims that the research performed by Hauser undercounted and excluded MAUDE data reports for Medtronic product resulting in substantial factual errors.

According to the press release: Continue reading→

St. Jude Warns Physicians of Potential Problem with QuickSite and QuickFlex LV CRT Leads

Posted on by Posted in Cardiac Pacing, Heart Failure (CHF), St. Jude Medical
St Jude QuickFlex lead

Image Credit: St. Jude Medical

St. Jude announced it is proactively informing physicians about visual observations of externalized conductors on the silicone end of QuickSite® and QuickFlex® Left-Ventricular Leads, used to connect Cardiac Resynchronization Therapy devices to the heart.

The announcement noted that there have been no reports of patient injury or loss of therapy due to externalized conductors in these leads, but as a conservative measure, St. Jude Medical is communicating with physicians about the incidence rate so they have the most updated lead performance information with which to make important patient care decisions.

According to the announcement, “St. Jude Medical has confirmed 39 cases of externalized conductors, out of 171,000 QuickSite and QuickFlex leads sold worldwide, resulting in a current reported incidence rate of 0.023 percent, or 2.3 in 10,000. Because these leads continue to function normally, the company expects that this rate is under-reported. Based on an analysis of leads returned to the company and recent fluoroscopic images of implanted leads still in clinical use, St. Jude Medical estimates that 3 to 4 percent of QuickSite and QuickFlex leads may exhibit externalized conductors. As a result of this estimated rate, the company felt it was prudent to communicate with physicians about the externalized conductors at this time.”

St. Jude also announced they will no longer sell these lead models.

St. Jude Medical Announces Clinical Benefits of Quadripolar CRT Pacing at ACC

Posted on by Posted in Cardiac Pacing, Heart Failure (CHF), St. Jude Medical
Quadrapolar cardiac resynchronization pacing St Jude Medical Unify Quadra www.implantable-device.com

Image Credit: St. Jude Medical

St. Jude Medical announced that clinical findings on quadripolar pacing will be presented at the 61st Annual Scientific Sessions of the American College of Cardiology (ACC, Chicago, March 24-27 2012).

According to St. Jude’s announcement, quadripolar pacing allows physicians the ability to use multisite left-ventricular (LV) pacing.  Studies that examined the role of multisite pacing in improving hemodynamics and reducing dyssynchrony as compared to traditional bi-ventricular pacing will be presented in the following two posters:

Continue reading→

Boston Scientific to Acquire Cameron Health for $150M Up-Front + $150M Upon FDA Approval

Posted on by Posted in AIMD Business, Boston Scientific, Cameron Health, Cardioversion/Defibrillation, News
Cameron Health S-ICD subcutaneous defibrillator

Image Credit: Boston Scientific

Boston Scientific announced the exercise of its option to acquire Cameron Health.  Cameron Health developed the world’s first and only commercially-available subcutaneous implantable cardioverter defibrillator – the S-ICD® System that I blogged about a few weeks ago.

The agreement calls for an upfront payment of $150 million, payable upon transaction closing, an additional potential $150 million payment upon FDA approval of the S-ICD System, plus up to an additional $1.050 billion of potential payments upon achievement of specified revenue-based milestones over a six-year period following FDA approval.  Closing of the transaction is subject to customary conditions, including relevant antitrust clearance, and is expected to occur in the second or third quarter of 2012.

Medtronic Receives CE Mark for CapSure Sense MRI™ SureScan® Pacing Leads

Posted on by Posted in Cardiac Pacing, Medtronic, MRI-safe
Medtronic SureScan Sense MRI Passive Fixation Leads. www.implantable-device.com

Image Credit: Medtronic

Medtronic today announced the receipt of CE Mark and launch of the CapSure Sense MRI™ SureScan® pacing leads, which are approved for use during MRI procedures.  The newly approved leads are the smallest MR–Conditional leads available in the world with a 5.3 French isodiametric lead body.  The new leads are passive-fixation leads.  Previously approved Medtronic MR–Conditional leads are active fixation leads.

Click here for Medtronic’s product page for the CapSure Sense MRI™ SureScan® Pacing Leads.

The Australian Pacemaker: Telectronics (1965-1995)

Posted on by Posted in Bradycardia, Cardiac Pacing, History, Museum, St. Jude Medical, Telectronics (1965-1995)

Telectronics model 150B VVI pacemaker photographed by David Prutchi, Ph.D. www.implantable-device.comIn 1965, Australian medical device pioneer Noel Gray established Telectronics – Australia’s first manufacturing facility for producing pacemakers that were designed in-house.  Telectronics was an innovative developer, achieving some major successes in the early cardiac pacing field, for example, Telectronics’ leads allowed narrowing the pacing pulse to its current nominal of 0.5 milliseconds; encapsulating the pacemaker in titanium instead of epoxy; using a microplasma weld to join the two halves of the pacemaker capsule; creating one of the first rate-responsive ‘demand’ pacemakers; and isolating the pacemaker’s battery in a separate compartment to deal with the problem of leaking mercury-zinc batteries. Continue reading→

Micro Systems Technologies Offers Active Implantable Medical Device Development/Manufacturing Services

Posted on by Posted in Biotronik, DYCONEX, LITRONIK Batterietechnologie, Micro Systems Engineering, Micro Systems Technologies
Micro Systems Technologies offers OEM services to AIMDs

Image Credit: Micro Systems Technologies

Micro Systems Technologies (MST) is the vertically-integrated supplier of microelectronics and implantable-grade components to Biotronik.  It now offers its development and manufacturing services to others.

Through its companies, MST offers high-reliability microelectronic modules for implantable medical devices such as pacemakers, defibrillators, neurostimulators, and cochlear implants.

MST can provide integrated solutions encompassing everything from conceptual design through high-volume surface-mount (SMT) assembly of modules. Services include design development of customer-defined electronic modules, custom ASIC design and development, and high-density-interconnect (HDI) substrate and assembly design.

As a OEM, MST offers state-of-the-art automated SMT line, an ISO 13485–compliant process and component verification and validation methodology, a manufacturing execution system that automates data collection, analysis, and process control, and comprehensive supply-chain management and monitoring with 100% traceability. Continue reading→

DF-4 Connectors for Implantable Cardioverter Defibrillators Enter Use in the US

Posted on by Posted in AIMD Business, Boston Scientific, Cardioversion/Defibrillation, Medtronic, St. Jude Medical, Tachycardia
DF-4 Connector for implantable cardioverter defibrillators

Image Credit: St. Jude Medical

The DF-4 Connector was recently introduced by a joint group of CRM companies, physicians, and regulatory agencies as a way of easing the implant of ICDs by reducing defibrillation connections from three to one and by minimizing the number of set screws.  Prior to the development of the DF-4, traditional high-voltage connector systems required up to three connections. Continue reading→

Boston Scientific’s Active Implantable Sales for 2011: CRM Down 7%, Neuromodulation Up 10%

Posted on by Posted in AIMD Business, Boston Scientific

Boston Scientific Logo

Today Boston Scientific Corporation announced financial results for the fourth quarter and full year ended December 31, 2011.  Summarizing the AIMD data:

  • On a constant-currency basis, Q4 2011 CRM sales were $482M compared to $564M in Q4 2010, or  down 15%
  • On a constant-currency basis, 2011 CRM sales were $2,087M compared to $2,180M in Q4 2010, or  down 7%
  • On a constant-currency basis, Q4 2011 Neuromodulation sales were $91M compared to $86M in Q4 2010, or  up 6%
  • On a constant-currency basis, Q4 2011 CRM sales were $336M compared to $304M in Q4 2010, or  up 10%

Click here for the news release.

 

 

Remon Medical’s Implantable Pulmonary Pressure Sensor (1997-2007)

Posted on by Posted in Boston Scientific, Heart Failure (CHF), History, Remon Medical (1997-2007), Telemetry

Remon Medical (now Boston Scientific) implantable pulmonary artery pressure sensor

Remon Medical Technologies, Ltd. was founded in 1997 in Caesarea, Israel to develop implantable, wireless pressure sensors.

Remon developed an implantable hemodynamic monitor, which allowed on-demand, non-invasive, leadless self-monitoring of pulmonary artery pressure by the patient at home. ImPressure devices were placed in the pulmonary artery, and transmitted pressure readings to a hand-held monitor.  It was hoped that the system would provide early warning of the need for treatment, avoiding hospitalization and deterioration in the patient’s condition. Continue reading→

SMSI® Implantable Glucose Sensor

Posted on by Posted in Diabetes, Sensors for Medicine and Science, Telemetry

SMSI implantable glucose sensor Sensors for Medicine and Science, Inc. (SMSI)  of Germantown, MD was founded in 1997 to develop chemical sensing technologies based on fluorescence sensing.

SMSI® is now developing an implantable glucose sensor that is designed to automatically measure interstitial glucose every few minutes. The sensor implant communicates wirelessly with a small external reader, allowing it to track the rate of change of glucose levels and warn the user of impending hypo- or hyperglycemia. According to SMSI, the target operational life of the sensor implant will be 6-12 months, after which it would be replaced. Continue reading→